50 Signatures Now on Specter-Harkin Letter

Almost two weeks ago C3 sent an action alert asking advocates to email their Senators to tell them to sign onto a letter initiated by Senators Arlen Specter (R-PA) and Tom Harkin (D-IA). This letter to the Senate leadership seeks continued Senate support to add $7 billion to the Labor-HHS-Educaton appropriation which would ultimately add more funds to cancer research.

Many of you contacted your Senators and that made a big difference because we now have 50 signatures on the letter…but we would like to get at least 19 more! We now know that Senators Specter and Harkin are not likely to send their letter to the Senate leadership until around the time the “lame-duck session” begins on November 13. This means that we have more time to work on these 19 Senators.

What can you do right now? That depends upon what your Senator did or did not do. If your Senator signed the letter send him or her a thank you note. If you Senator voted for the Specter-Harkin amendment and has not signed the letter tell him or her you want that signature. See the two lists at the end of this post to find out which Senators took what action.

You can also get your family and friends involved. Congress pays attention to numbers. Therefore, the more people who contact their Senators asking them to sign the letter the more likely it is that those Senators will sign.

Click here to go to the Specter-Harkin letter page in the One-Minute Advocate area of the C3 web site.

It is because of people like you taking action that 21 additional Senators signed the letter since the action alert was sent. Thank you very much for all you did and continue to do in the fight against colon and rectal cancer. We will keep you informed as the letter moves through the process and is ultimately delivered to the Senate leadership.

These Senators voted FOR the Specter-Harkn amendment to add $7 billion to the Labor-HHS-Education appropriation AND HAVE NOT signed the letter to the Senate leadership (as of September 26). You still have opportunity to tell them to sign.

Murkowski (Alaska)

Stevens (Alaska)

Lincoln (Arkansas)

Feinstein (California)

Bayh (Indiana)

Grassley (Iowa)

Lott (Mississippi)

Talent (Missouri)

Hagel (Nebraska)

Domenici (New Mexico)

Dole (North Carolina)

Conrad (North Dakota)

Voinovich (Ohio)

Santorum (Pennsylvania)

Thune (South Dakota)

Alexander (Tennessee)

Hutchison (Texas)

Bennett (Utah)

Warner (Virginia)

These Senators voted FOR the Specter-Harkin Amendment to add $7 billion to the Labor-HHS-Education appropriation AND signed the letter to Senate leadership. Send these Senators a thank you note.

Pryor (Arkansas)

Boxer (California)

Salazar (Colorado)

Dodd (Connecticut)

Lieberman (Connecticut)

Biden (Delaware)

Carper (Deleware)

Nelson (Florida)

Akaka (Hawaii)

Inouye (Hawaii)

Harkin (Iowa)

Durbin (Illinois)

Obama (Illinois)

Lugar (Indiana)

Roberts (Kansas)

Landrieu (Louisiana)

Collins (Maine)

Snowe (Maine)

Mikulski (Maryland)

Sarbanes (Maryland)

Kerry (Massachusetts)

Kennedy (Massachusetts)

Stabenow (Michigan)

Levin (Michigan)

Dayton (Minnesota)

Coleman (Minnesota)

Baucus (Montana)

Burns (Montana)

Nelson (Nebraska)

Lautenberg (New Jersey)

Menendez (New Jersey)

Bingaman (New Mexico)

Clinton (New York)

Schumer (New York)

Dorgan (North Dakota)

DeWine (Ohio)

Smith (Oregon)

Wyden (Oregon)

Specter (Pennsylvania)

Chafee (Rhode Island)

Reed (Rhode Island)

Johnson (South Dakota)

Hatch (Utah)

Jeffords (Vermont)

Leahy (Vermont)

Cantwell (Washington)

Murry (Washington)

Rockefeller (West Virginia)

Feingold (Wisconsin)

Kohl (Wisconsin)

Posted by Dusty Weaver on September 30th, 2006
Posted in: Policy & Advocacy News | No Comments »

To Make Cancer an Issue You Have to Ask the Question

Between now and the November electon candidates for Congress will make many apperances on the campaign trail. This means colon and rectal cancer advocates will have opportunity to make cancer an issue. Jim Wetekam, C3 Director of Policy Communications, came up with some great ideas for you to use at any open fourm featuring your current Senator or Representative as well as others running for the office.

Remember to arrive early as this will allow you to sit in the front row or other prominent location in order to be recognized for a question. If microphones are set up, sit near one and immediately go to it when the floor is opened for questions.

Before the event’s start, talk to staff and let them know you would like to ask a question about cancer funding as they may help facilitate this for you. Remember to exchange business cards either before or after the event with any staff present. Try to have an informal conversation after the event with either the current office holder or the opponent.

Reporters may be present so be sure to talk to them. Rebecca Dague, C3 advocate living in Ohio, found the person from the local paper and talked to him before the forum. She introduced herself to him and made sure to sit at the same table as he did. The result was her question to Representative Ralph Regula and his response were reported in the newspaper the next day. Click here to read a post about Rebecca’s experience.

Now is not the time to make a long speech. A one or two sentence statement followed by a good question is much more effective.

Here are some suggestions:

Cancer kills 1,500 Americans every day, yet the President and the House of Representatives are proposing cuts to critical cancer research and programs that help people get life-saving screenings and treatment. The Senate bill is not much better at this point. Will you oppose an funding bill that cuts cancer funding?

As a colorectal cancer survivor, I am incredibly grateful for the past investment in cancer resaerch that led to the screenings and treatments that have saved my life. I am disturbed to find out that the House of Representatives this year is proposing cuts to cancer research and to cancer prevention programs in the bill that funds these programs. The Senate bill is not much better. Will you agree to oppose any bill that cuts cancer funding so as to ensure we can continue making progress toward finding more and better screening and treatments for this disease?

The House and Senate are both on record as supporting an increase of $7 billion in fiscal year 2007 for crucial health as well as other programs, yet the appropriations bills from both sides of Congress are billions short of that commitment (the House by $3 billion and the Senate by $2 billion). Will you support the full $7 billion needed in the Labor-HHS-Education Appropriation bill to keep us on pace in the war against cancer?

Feel free to adapt these to your cancer experience, the type of forum, and the person or persons whom you ask.

Posted by Dusty Weaver on September 30th, 2006
Posted in: Policy & Advocacy News | No Comments »

Amgen Oncology Assistance program will provide financial help for cancer treatments

Amgen has announced that is is offering comprehensive financial assistance to help patients use its cancer medicines. The program includes a cap on out-of-pocket payments for patients receiving Vectibix™, the newly FDA-approved Amgen treatment for metastatic colon and rectal cancer.  The Amgen Oncology Assistance program will be available for uninsured, underinsured, and patients who are unable to afford co-payments for Amgen oncology drugs.  Assistance will be provided through the Amgen SAFETY NET® Foundation.

The Amgen Oncology Assistance program includes:

• Vectibix Cap:  patients, regardless of insurance or income, will be eligible for SAFETY NET assistance once their co-payments for Vectibix (panitumumab) reach 5% of their gross income.
• Uninsured or underinsured patients with gross incomes under $75,000 can receive Amgen oncology medicines at no cost through SAFETY NET.
• Financial assistance for low income or uninsured patients is also available through independent, third-party patient assistance programs who receive charitable donations from Amgen to help patients with the cost of treatment.

Patients or their doctors can contact the SAFETY NET program through Amgen’s Reimbursement Connection online or by calling 1–800–272–9376. 

The Reimbursement Connection can also help physicians and oncology office staff with insurance reimbursement questions, coding, preauthorization support, and insurance appeals information, as well as assisting them and their patients in locating payment resources.

Posted by Kate Murphy on September 28th, 2006
Posted in: Research & Treatment News | 2 Comments »

FDA approves Vectibix for treatment of colon and rectal cancer

Click here for C3’s official statement on the approval of Vectibix

On September 27, 2006 the Food and Drug Administration (FDA) announced their approval of Vectibix™ (panitumumab) for the treatment of colon and rectal cancer that has spread to other parts of the body (metastasized). The FDA approved labeling is for cancer that has  progressed during or after chemotherapy treatment with fluoropyrimidine, irinotecan, and oxaliplatin regimens.

Vectibix is an entirely human monoclonal antibody that binds to and blocks the activity of the epidermal growth factor receptors (EGFR) on cancer cells.  Epidermal growth factor is a protein that promotes the growth of cells, including cancer cells.

Approval was based a randomized clinical trial that compared treatment with Vectibix and best supportive care to best supportive care alone. In the trial 463 patients were randomly assigned to receive either Vectibix as a single drug (monotherapy) every two weeks or supportive care alone.  Supportive care included medication for pain, surgery or radiation to treat pain, blood transfusions, or other treatments to manage symptoms but not chemotherapy.  All patients in the trial were no longer responding to standard treatments that included fluoropryrimidines, irinotecan, and oxaliplatin (refractory).

Patients on Vectibix in the trial had a 46% longer progression-free survival than those on best supportive care.  In addition, 8% of patients had metastatic tumors reduced during treatment while no patients in the best supportive care arm experienced tumor response.  Twenty-eight percent of Vectibix patients had a period of stable disease (no growth of cancer) while on the drug compared to 10% of those in the best supportive care arm.  These results translate into disease control for 36% of Vectibix patients and 10% of the best supportive care group.

A video web cast by Dr. Marc Peeters of the design and results of the clinical trial is available on the 2006 American Association for Cancer Research virtual meeting.  To see Dr. Peeters’ presentation enter the word “panitumumab” at the AACR webcast sessions site.  More details about the trial results are available on Medical News Today.

Skin rash was the most common side effect with 89% of patients experiencing rash and 12% having a severe rash.  Skin reactions to Vectibix included an acne-like rash, itching, redness and swelling, dry skin, and breaks in the skin. Some severe rash led to infection, abcesses, and sepsis.  Amgen, the manufacturers of Vectibix, warn, “Vectibix may need to be withheld or discontinued for severe dermatologic toxicities.”

Other side effects included fatigue, diarrhea, nausea and vomiting, and abdominal pain.  38% of patients had lowered magnesium levels with 3% experiencing severe drops in magnesium that required treatment.

Allergic reactions during infusion of monoclonal antibodies have been a problem with other biologic agents that block EGFR.  Since Vectibix contains no animal proteins, infusion reactions are expected to be less frequent and less severe. According to a press release from Amgen:

Severe infusion reactions occurred with Vectibix in approximately 1 percent of patients. Severe infusion reactions were identified as anaphylactic reactions, bronchospasm, fever, chills, and hypotension. Although fatal infusion reactions have not been reported with Vectibix, they have occurred with other monoclonal antibody products. Severe infusion reactions require stopping the infusion and possibly permanently discontinuing Vectibix, depending on the severity and/or persistence of the reaction.

While the FDA approval of Vectibix was based on progression-free survival in a randomized clinical trial of patients with refractory colorectal cancer, clinical trials are ongoing to study it in combination with chemotherapy and in other situations.  A large randomized Phase 3 trial  (PACCE) is underway to compare the effectiveness of adding Vectibix (panitumumab) to chemotherapy with bevacizumab (Avastin™) to improve progression-free survival as first-line treatment for metastatic colorectal cancer.

WHAT THIS MEANS FOR PATIENTS

There is currently evidence that Vectibix™ (panitumumab) increases the time until cancer begins to progress again for patients who have already been treated with standard chemotherapy.  Some patients (about 8%) will also experience a decrease in the size of their tumors. The FDA approval is based on this evidence.

At this time, Vectibix is an appropriate treatment:

• For patients whose cancer is refractory to standard chemotherapy — who have already been treated with a fluoropryrimidine such as 5FU (fluorouracil) or capecitabine (Xeloda™), irinotecan (Camptosar™), and oxaliplatin (Eloxatin™).
• As monotherapy (a single drug)
• In cases where the patient has not already received cetuximab (Erbitux)

While there is a strong theoretical rationale for trying Vectibix in patients who were forced to discontinue Erbitux because of allergic reactions to it, more data is needed to establish its safety in such settings.

Clinical trials are underway and seeking patients to explore the safety and effectiveness of Vectibix in other colorectal cancer situations.  Patients who are seeking a clinical trial for colon or rectal cancer can find more information on the National Cancer Institute web site or by calling the C3: Colorectal Cancer Clinical Trials Matching Service at 1–866–278–0392.

Posted by Kate Murphy on September 28th, 2006
Posted in: Research & Treatment News | 1 Comment »

Music eases pain and worries during colonoscopy

Despite the availability of sedative drugs, many people worry that colonoscopy will be painful.  They put off a screening test that can prevent colon or rectal cancer by finding and removing pre-cancerous polyps or that can reduce death from colorectal cancer by finding and treating it early.  In addition, sedation increases the risk of the colonoscopy procedure.

Researchers at Temple University in Philadelphia found that playing music chosen by patients significantly reduced the amount of sedation they required during their colonoscopies. 

Patients were invited to bring favorite music from home or to choose something they liked from available CD’s.  After sedation began, patients were randomly assigned to hear the music or not.  After the colonoscopy, someone from the medical team evaluated the patient’s pain, anxiety, and comfort levels.  Later a second researcher interviewed the patient.

Patients who listened to music required about one less dose of sedation (3.8 mg of midazolam vs. 4.4 mg, and 87 mcg of fentanyl vs. 93 mcg) yet said they were as comfortable during the procedure as patients who didn’t hear music and needed a higher dose of drugs.

Benjamin Krevsky, MD MPH, who led the study said, “”Over all, colonoscopies are very, very safe, and while the risks of sedatives are relatively small, in general, less medication is always better.”   Krevsky also believes that lower doses of medication may lead to lower healthcare costs.

Dr. Krevsky is a professor of medicine at Temple University School of Medicine and director of gastrointestinal endoscopy at Temple University Hospital.  His research was presented as a poster during Digestive Disease Week 2006 in Los Angeles in May.

Posted by Kate Murphy on September 27th, 2006
Posted in: Research & Treatment News | No Comments »